The Recall Desk
HighFDA (Drugs)·D-0860-2023·Announced 2023-06-07

Prescription eye solution recalled due to discontinued stability studies

Akorn, Inc. is recalling all lots of Olopatadine HCl ophthalmic solution 0.2% because the company went out of business and can no longer conduct required stability testing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recalls with hospitalization reports warrant severity of 4, but this recall reports no illnesses or injuries. The hazard is a manufacturing practice deviation affecting stability verification—a risk-of-harm product without confirmed harm, warranting severity of 3.

Plain-English summary

Akorn, Inc. is recalling all lots of Olopatadine HCl ophthalmic solution 0.2% distributed nationwide in the USA and Puerto Rico.

The FDA classified this as a Class II recall due to a Current Good Manufacturing Practice (CGMP) deviation. Akorn, Inc. ceased business operations and can no longer conduct the stability studies required to verify the product remains safe and effective throughout its shelf life.

The recalled product

Product
Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
  • cgmp-deviation
  • unverified-stability

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

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